Syeda

Drospirenone and Ethinyl Estradiol · KIT · Xiromed, LLC.

No Recall HistoryCurrently in Shortage

Plain English

Syeda is a kit containing drospirenone and ethinyl estradiol. Manufactured by Xiromed, LLC..

Key Facts

Brand Name: Syeda
Generic Name: Drospirenone and Ethinyl Estradiol
NDC Code (Product): 70700-115
Manufacturer: Xiromed, LLC.
Dosage Form: KIT
Marketing Status
Application #: ANDA090114
Marketing Start: 12/01/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain1,723 reports

injury1,301 reports

cholecystitis chronic1,024 reports

anxiety791 reports

gallbladder disorder777 reports

pulmonary embolism763 reports

deep vein thrombosis719 reports

emotional distress689 reports

cholelithiasis672 reports

abdominal pain359 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Syeda ® (drospirenone and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. Syeda ® (drospirenone and ethinyl estradiol tablets) is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.1 ) Tablets must be taken in the order directed on the blister pack. ( 2.1 ) 2.1 How to Take Syeda Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive effectiveness, Syeda must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. 2.2 How to Start Syeda Instruct the patient to begin taking Syeda either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). Day 1 Start During the first cycle of Syeda use, instruct the patient to take one yellow Syeda daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one yellow Syeda daily for 21 consecutive days, followed by one white tablet daily on Days 22 through 28. Syeda should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Syeda can be taken wi…

Contraindications

4 CONTRAINDICATIONS Syeda is contraindicated in females who are known to have or develop the following conditions: Renal impairment Adrenal insufficiency A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see BOXED WARNING AND WARNINGS AND PRECAUTIONS( 5.1 )] Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS ( 5.1 )] Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] Have coronary artery disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrilation) [see WARNINGS AND PRECAUTIONS ( 5.1 )] Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS ( 5.1 )] Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS ( 5.6 )] Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS ( 5.8 )] Have headaches with focal neurological symptoms or have migrane headaches with or without aura if over age 35 [see WARNINGS AND PRECAUTIONS ( 5.9 )] Undiagnosed abnormal uterine bleeding…

Drug Interactions

7 DRUG INTERACTIONS Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations . Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. ( 7.1 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS ( 5.1 ) ] Vascular events [see WARNINGS AND PRECAUTIONS ( 5.1 ) ] Liver disease [see WARNINGS AND PRECAUTIONS ( 5.4 ) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most frequent adverse reactions (a2%) are premenstrual syndrome (13.2%), headache /migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%), abdominal pain/tenderness/discomfort (2.3%), mood changes (2.3%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC. at 1-844-XIROMED (1-844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. The data provided reflect the experience with the use of drospirenone and ethinyl estradiol(3 mg DRSP/0.03 mg EE…

Frequently Asked Questions

What is Syeda used for?

Syeda contains Drospirenone and Ethinyl Estradiol. It is a kit taken as directed. Consult your doctor for specific uses.

Is Syeda a controlled substance?

Syeda is not classified as a controlled substance by the DEA.

What is the generic name for Syeda?

The generic name for Syeda is Drospirenone and Ethinyl Estradiol. There are 11 other brand versions of Drospirenone and Ethinyl Estradiol.

What is the NDC code for Syeda ?

The NDC (National Drug Code) for Syeda is 70700-115, listed by Xiromed, LLC..

Product NDC

70700-115

Package NDC

70700-115-85

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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